Clinical Trial Assistant

Position Summary The Clinical Trial Assistant (CTA) provides operational and administrative support for the planning, execution, and closeout of clinical trials. Reporting to the Clinical Trial Manager or Clinical Operations Lead, the CTA plays a key role in maintaining trial documentation, coordinating study activities, supporting vendor and site communications, and ensuring clinical studies are conducted in compliance with Good Clinical Practice (ICH-GCP), applicable regulations, company Standard Operating Procedures (SOPs), and study protocols. As part of a small, collaborative biotech company, the CTA will work closely with cross-functional teams and external partners, including Contract Research Organizations (CROs), study sites, central laboratories, and vendors. The ideal candidate is highly organized, proactive, adaptable, and eager to contribute to a fast-paced clinical development environment. Key Responsibilitie sClinical Trial Suppor tProvide day-to-day operational support for Phase I–IV clinical studies .Assist Clinical Trial Managers with study start-up, conduct, maintenance, and closeout activities .Track study milestones, timelines, and action items to support successful study execution .Coordinate investigator meeting logistics, study team meetings, and meeting minutes .Assist with study-specific documentation and operational deliverables .Trial Master File (TMF) Managemen tMaintain the electronic Trial Master File (eTMF) to ensure documents are complete, accurate, and inspection-ready .Review study documentation for quality, completeness, and filing accuracy .Track outstanding documents and follow up with internal teams, CROs, and study sites .Support periodic TMF quality reviews and reconciliation activities .Vendor and CRO Coordinatio nSupport communication with CROs and external vendors .Track vendor deliverables and assist with issue resolution .Coordinate document exchange between internal teams and external partners .Assist with vendor onboarding and maintenance of study documentation .Site and Investigator Suppor tAssist with investigator site activation activities, including collection and tracking of essential documents .Coordinate shipment of study materials, regulatory packets, and investigator communications .Respond to routine site inquiries and route questions to appropriate team members .Support site payment tracking and study supply coordination, as applicable .Regulatory and Compliance Suppor tAssist with preparation and maintenance of essential regulatory documentation .Ensure study documentation complies with ICH-GCP, company SOPs, and applicable regulatory requirements .Support inspection readiness activities and internal quality reviews .Maintain study trackers and regulatory logs .Clinical Systems and Documentatio nMaintain study information within clinical systems (CTMS, eTMF, EDC, and document management systems) .Generate reports, study metrics, and status updates as requested .Support user access requests and document version control .Assist with maintaining study correspondence and filing .Cross-Functional Collaboratio nCollaborate with Clinical Operations, Regulatory Affairs, Data Management, Clinical Supply, Medical Writing, Pharmacovigilance, Quality Assurance, and Finance .Support study planning and operational meetings .Participate in process improvement initiatives and SOP development as appropriate .Contribute to a collaborative, team-oriented environment .Administrative Suppor tCoordinate travel arrangements and meeting logistics for study teams .Prepare agendas, meeting materials, and meeting minutes .Organize study documentation and maintain study trackers .Assist with purchase orders, invoices, and vendor payment documentation . Qualificatio nsEducati onBachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field preferre d.Equivalent combination of education and relevant clinical research experience will be considere d.Experien ce1–3 years of experience supporting clinical trials in a biotechnology, pharmaceutical, CRO, or academic research settin g.Experience as a Clinical Trial Assistant, Clinical Research Coordinator, or similar role preferre d.Experience supporting outsourced clinical trials is desirabl e.